Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

Golden Gate Study : Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

40-100Age 40-100

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaAcute Lymphoblastic Lymphoma

Trial Overview Read MoreRead more

This phase III study is comparing a combined treatment of targeted therapy (blinatumomab) and low-intensity chemotherapy to standard of care chemotherapy in older adults with newly diagnosed Philadelphia-negative B-cell precursor Acute Lymphoblastic Leukaemia.
 

This trial is treating patients with Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukaemia.

This is a systemic therapy trial.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)

Commercial Sponsor

AMGEN

Summary

This study has a safety run-in part which will be performed prior to initiating the phase 3 randomised part of the study. The safety run-in aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy, and also evaluates a shorter dose step interval from 4 days (instead of 7 days) and a 1-week (instead of 2-week) drug free interval between blinatumomab cycles. Blinatumomab will be infused at a lower dose for 4 days and increase to a higher dose on Day 5 of the infusion for the remainder of the infusion. Once the safety run-in is complete, the randomised part oft he study will commence. This part has an Experimental Arm and an Active Comparator Arm. In the Experimental Arm, participants will receive Blinatumomab (intravenously) alternating with a low-intensity chemotherapy regimen. In the Active Comparator Arm, participants will receive 1 of 2 standard of care chemotherapy regiments (GMALL or HyperCVAD) per investigator's choice.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Malignant Haematology & Stem Cell Transplantation Service
Prahran
Ms Nola Kennedy
n.kennedy@alfred.org.au
03 9076 2217

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Jessica Ahern
PCCTU.HaemA@petermac.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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